Associate Specialist Downstream Operations (m/w/d)

For one of our clients, a leading biotechnology company in the greater Lucerne area, we are currently seeking an Associate Specialist Downstream Operations (m/w/d) to join their manufacturing team in Schachen.

In this hands-on role, you will contribute to the GMP manufacturing of innovative early-phase clinical therapies, playing a key part in the production of biologics that support the development of next-generation treatments. Working as part of a collaborative and highly skilled manufacturing team, you will support downstream processing activities while ensuring the highest standards of quality, compliance, and operational excellence.

This is an on-site position requiring full-time presence in Schachen to support manufacturing operations and facilitate close collaboration with cross-functional teams.

Your Responsibilities:

• Set up, practical execution and troubleshooting of downstream processes under Good Manufacturing Practices (GMP) 
• Knowledge of and compliance to GMP principles and EHS standards in the area of responsibility
• Involvement in continuous improvement efforts and support for the implementation of new technologies, including non-GMP engineering runs or testing activities
• Creation and updates of SOPs and (electronic) master batch records. Technical review of various documentation related to process transfer and GMP manufacturing
• Material management using ERP systems (SAP)
• Participation in sampling activities (including occasional weekend work) or on-call duties, as required by the process scheduling. Typical manufacturing activities do not include shift work. 

Your profile:

• Bachelor's or Master's degree in Biotechnology, Life Sciences, Engineering, or a related discipline.
• Minimum of 1-2 years of experience in the pharmaceutical or biotechnology industry.
• Previous experience in biologics manufacturing within a GMP-regulated environment. Hands-on experience with capture and polishing chromatography, virus filtration, UF/DF, formulation, fill, and freeze processes would be a strong advantage.
• Experience working with manufacturing automation systems such as DeltaV and electronic batch record systems such as PAS-X is highly desirable.
• Strong problem-solving skills with the ability to challenge existing approaches, explore innovative solutions, and continuously learn and improve.
• Ability to perform effectively under pressure in a complex GMP environment while taking ownership and accountability for assigned responsibilities.
• Flexible and collaborative mindset, with the ability to work effectively with internal and external stakeholders to achieve ambitious operational goals.
• Fluent communication skills in both German and English:
  • German: C1 level (written and spoken)
  • English: B2+ level (written and spoken)
• Residence within approximately 30 minutes commuting distance of Schachen (LU), or willingness to relocate.
• Valid Category B driving licence and access to a personal vehicle to support on-call responsibilities.

Additional Information:

• This is a site-based role, 5 days per week.
• Location: Schachen
• Contract duration: This is a 12-month contract position, planned to start in September, with the possibility of extension.
• Type of employment: Temporary staffing